S.2917 - Adding Ebola to the FDA Priority Review Voucher Program Act113th Congress (2013-2014)
|Sponsor:||Sen. Harkin, Tom [D-IA] (Introduced 11/12/2014)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||12/16/2014 Became Public Law No: 113-233. (TXT | PDF) (All Actions)|
This bill has the status Became Law
Here are the steps for Status of Legislation:
- Passed Senate
- Passed House
- To President
- Became Law
Summary: S.2917 — 113th Congress (2013-2014)All Information (Except Text)
Public Law No: 113-233 (12/16/2014)
(This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)
Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)
Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).
Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.